Maxillary ExpansionNCT05743127
3D-Printed Versus Laboratory-Fabricated Hyrax Expanders
A study testing 3D-Printed Hyrax Expander and Conventional Laboratory Fabricated Hyrax Expander in people with Maxillary Expansion, run by Ildeu Andrade Jr. at 2 sites in United States.
Trial summary
Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Expansion
- What is being tested?
- 3D-Printed Hyrax Expander and Conventional Laboratory Fabricated Hyrax Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Maxillary anterior and/or posterior transverse deficiency with or without crossbite
- Age of 8-13 years
- Children whose parents/guardians are willing to consent to the child participating in the study
- Children ages 12-13 who are willing to assent to participating in the study
- Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine
- Subjects and parents/guardians who have access to an electronic device with internet connection
Who cannot join
- Patients with previous or ongoing orthodontic treatment
- Patients whose parents have a strong preference as to which expander is used
- Patients with a history of temporomandibular disorders
- Presence of congenitally missing teeth
- Traumatic loss of maxillary incisors
- Patients with craniofacial syndromes, or cleft lip and/or palate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Ildeu Andrade, DDS, MS, PhD, 8437923366, andradei@musc.edu
- Recruiting
University of Pittsburgh - School of Dental Medicine
Pittsburgh, Pennsylvania, 15213
Ildeu Andrade, DDS, MS, PhD, 412-648-3369, ildeu.andrade@pitt.edu
About this study
Official title: 3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.
- Conditions
- Maxillary Expansion
- Being tested
- 3D-Printed Hyrax Expander, Conventional Laboratory Fabricated Hyrax Expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Hyrax ExpanderDevice
This is a type of maxillary expander that is designed on a computer and printed in metal using 3D printers and is used to expand the upper jaw.
Conventional Laboratory Fabricated Hyrax ExpanderDevice
This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.
| Study group | Role | What they receive |
|---|---|---|
| Group Conventional Expander | Experimental | Conventional Laboratory Fabricated Hyrax Expander Receives: Device: Conventional Laboratory Fabricated Hyrax Expander |
| Group 3-D Printed Expander | Experimental | 3D-Printed Hyrax Expander Receives: Device: 3D-Printed Hyrax Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimension of the Anterior Midpalatal Suture Opening
The dimension of the anterior midpalatal suture opening between the maxillary halves will be measured digitally in millimeters on the occlusal radiograph using a calibrated ruler.
Measured: 2 weeks
Secondary outcomes (6)
Change in Interincisal Diastema Width
The change in interincisal diastema width will be measured in millimeters on the post-expansion (T1) digital models between the maxillary central incisors using OrthoAnalyzer 3D software.
Measured: 2 weeks
Change in Maxillary Molar Inclination
Using measurement tools in OrthoAnalyzer 3D software and the T0 digital models, the inter-molar inclination of the maxillary permanent first molars will be evaluated. The inclination of the T1 maxillary permanent first molars will be measured in a like-manner as the T0 digital models. The intermolar inclination measurement at T1 will be subtracted from the intermolar inclination measurement at T0 to record any presumably positive increase in molar inclination.
Measured: 2 weeks
Change in Maxillary Arch Widths
The measurements of the maxillary dental arch widths will be performed on the pre-expansion (T0) and post-expansion (T1) digital models using the OrthoAnalyzer software. The intercanine, interpremolar or first deciduous molar, and intermolar widths will be measured in millimeters. The widths at T0 will be subtracted from the widths at T1 to record any positive increase in arch widths.
Measured: 2 weeks
Pain Perception assessed by Visual Analog Scale
Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the visual analog scale (VAS). The higher the value in the VAS scale, the more severe the pain.
Measured: 2 weeks
Pain Perception assessed by Wong-Baker FACES Scale
Using an online questionnaire, patients will be asked about the highest pain level they will have experienced at different time points using the Wong-Baker FACES Scale. The more upset the face in the Wong-Baker FACES Scale, the more severe the pain.
Measured: 2 weeks
Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14
Using an online questionnaire, patients will be asked about his/her quality of life at different time points using the short version of the Oral Health Impact Profile (OHIP-14). The OHIP-14 has 14 questions distributed across seven domains: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The scores for each domain and the total score will be evaluated. A higher score indicates a more negative perception of the individual with respect his/her quality of life. The lowest score is 0, which indicates a more positive perception of the individual with respect his/her quality of life. The highest score is 4, which indicates a more negative perception of the individual with respect his/her quality of life.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ExpansionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ildeu Andrade Jr.
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Orthodontics Foundation
- Responsible party
- Sponsor-investigator, Ildeu Andrade Jr., University of Pittsburgh
- Investigators
- Ildeu Andrade, DDS, MS, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743127
- Sponsor's protocol ID
- STUDY24070148
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05743127
- Acronym / sponsor ID
- STUDY24070148
- Conditions
- Maxillary Expansion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ildeu Andrade Jr.University, hospital or other
- Collaborators
- American Association of Orthodontics Foundation
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Conventional Expander | Experimental | Device: Conventional Laboratory Fabricated Hyrax ExpanderConventional Laboratory Fabricated Hyrax Expander |
| Group 3-D Printed Expander | Experimental | Device: 3D-Printed Hyrax Expander3D-Printed Hyrax Expander |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Maxillary anterior and/or posterior transverse deficiency with or without crossbite
- Age of 8-13 years
- Children whose parents/guardians are willing to consent to the child participating in the study
- Children ages 12-13 who are willing to assent to participating in the study
- Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine
Key exclusion criteria (6 listed)
- Patients with previous or ongoing orthodontic treatment
- Patients whose parents have a strong preference as to which expander is used
- Patients with a history of temporomandibular disorders
- Presence of congenitally missing teeth
- Traumatic loss of maxillary incisors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Hyrax ExpanderThis is a type of maxillary expander that is designed on a computer and printed in metal using 3D printers and is used to expand the upper jaw. | Device | Group 3-D Printed Expander |
| Conventional Laboratory Fabricated Hyrax ExpanderThis is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw. | Device | Group Conventional Expander |
Primary outcome
Dimension of the Anterior Midpalatal Suture Opening
Time frame: 2 weeks
The dimension of the anterior midpalatal suture opening between the maxillary halves will be measured digitally in millimeters on the occlusal radiograph using a calibrated ruler.
6 secondary outcomes
Change in Interincisal Diastema Width
Time frame: 2 weeks
Change in Maxillary Molar Inclination
Time frame: 2 weeks
Change in Maxillary Arch Widths
Time frame: 2 weeks
Pain Perception assessed by Visual Analog Scale
Time frame: 2 weeks
Pain Perception assessed by Wong-Baker FACES Scale
Time frame: 2 weeks
Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Maxillary Expansion
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Not yet recruiting
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ildeu Andrade, DDS, MS, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Hyrax Expander and Conventional Laboratory Fabricated Hyrax Expander in people with Maxillary Expansion, run by Ildeu Andrade Jr. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ildeu Andrade, DDS, MS, PhD (843-792-3366, ildeu.andrade@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimension of the Anterior Midpalatal Suture Opening (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.